Intraaortic balloon counterpulsation in acute myocardial. Fibroblast growth factor 23 in acute myocardial infarction complicated by cardiogenic shock. Reviewing iabp use after recent clinical trials cath lab digest. More than 95% underwent primary pci with stent placement in 90%. No other percutaneous support device has proven superiority over iabps for treating patients with acute coronary syndrome and other complications of heart failure. Iabpshock ii with dr holger thiele trial and pis youtube. Intraaortic balloon therapy aids cardiogenic shock patients. Intraaortic balloon support for myocardial infarction with. Intraaortic balloon pump in cardiogenic shock ii iabpshock ii. Iabpshock ii trial results time to bailout iabp in the cardiogenic shock. A model was developed on the randomized population of the iabp shock ii trial n 600 using a stepwise multivariable cox proportional hazards regression analysis with forward selection technique.
Iabp offered no mortality benefits at 30 days in the 600patient iabp shock ii trial. The scoring system iabpshock ii score was determined by rounding the respective parameter estimates, attributing either 1 or 2 points to the variables. In the iabpshock ii trial and registry, patients with missing data with. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabpshock ii. Of course, we have to be careful about any nonrandomized analysis because of unmeasured confounders. In the largest randomised trial iabpshock ii, iabp support did. Iabpshock ii risk score american college of cardiology. The potential limitation of our study is that iabpshock ii trial may have relatively larger weight. Although there has been only limited evidence from randomised controlled trials, the previous guidelines of the american heart associationamerican college of cardiology ahaacc and the european. The iabp shock ii trial was a multicenter, openlabel, randomized study. The last chapter of the iabpshock ii study was the recently. In the iabpshock ii trial, iabp support did not result in a 30day mortality benefit in comparison to optimal medical therapy in patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization. Intraaortic balloon pump in cardiogenic shock ii iabp. In the largest randomised trial iabp shock ii, iabp support did not reduce 30 day mortality compared with control.
Intraaortic balloon pump therapy has now been studied for 30 years, in the context of no reperfusion, fibrinolysis, and primary pci. Following presentation, patients with cs were randomly assigned to either iabp n300 or conventional treatment n298. Iabp shock ii trial and the 30day and 12month results, including. The iabpshock ii trial was a multicenter, openlabel, randomized study. Objectives the aim of this study was to determine whether a new percutaneous. Intraaortic balloon pump in cardiogenic shock complicating. Intra aortic balloon counterpulsation learning package. Iabp failed to reduce 30day mortality in patients with cardiogenic shock. No mortality reduction with iabp in acute mi patients with.
Six variables can predict mortality risk in cardiogenic shock. The trial design of the randomized, openlabel, multicenter. Intraaortic balloon pump may grant no benefit to improve th. The trial design of the randomized, openlabel, multicenter iabp shock ii trial and the 30day and 12month results, including the primary end point have been previously published. In this randomized, prospective, openlabel, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon. We performed a literature search of the pubmed, medline, cochrane, and embase databases until december 31, 2015 using the key words, intraaortic balloon pump, percutaneous coronary intervention, myocardial infarction, acute coronary syndrome, and unstable angina. The current metaanalysis was conducted in accordance with the prisma guidelines. Recently, the large randomized iabp shock ii trial did not show a significant reduction in 30day mortality in csmi with iabp insertion. Iabpshock ii trial results time to bailout iabp in the.
Nov 02, 2012 dr holger thiele university of leipzig, germany gives an overview of the randomized comparison of intraaortic balloon counterpulsation vs optimal medical therapy in addition to early. Kg honoraria bayer corporation genzyme corporation interventional cardiologist clinical cardiovascular mri and vascular ultrasound research grants nhlb, ahrq, astrazeneca, pleuristem, johnson and. Thiele h, zeymer u, neumann fj, et al on behalf of the intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial investigators. Intraaortic balloon therapy aids cardiogenic shock patients september 10, 2012 maquet cardiovascular llc announced 30day results from the large, randomized, multicenter intraaortic balloon pump iabp shock ii clinical trial in patients with acute myocardial infarction ami who were in cardiogenic shock and undergoing early. Intraaortic balloon pump iabp has been extensively used in clinical practice as a. Divaka perera, matthew lumley, and nico pijls, recently wrote an editorial in circulation. Longterm 6year outcome of the randomized iabp shock ii trial. Iabpshockii trial zeitlicher verlauf meilenstein 2 1. This is a substudy of the randomized iabp shock ii trial. Randomized comparison of optimal medical therapy in. This is an overall synopsis of what we need to know regarding iabp. Principles of intraaortic balloon pump counterpulsation murli krishna mbbs frca ffpmrca kai zacharowski md phd frca intraaortic balloon pump iabp remains the most widely used circulatory assist device in critically ill patients with cardiac disease. As omerovic noted to the europcr audience, european society of cardiology esc guidelines that once gave iabps a class i recommendation for cardiogenic shock downgraded that guidance to class iii after the randomized iabpshock ii trial failed to find a 1year survival benefit in.
The intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial randomized 600 patients with acute mi complicated by cardiogenic shock to either iabp or no iabp. Percutaneous mechanical support in cardiogenic shock. This study reports on the iabpshock ii risk score, a simple tool that can be rapidly. Based upon results from the iabpshock pilot trial, the 2012 esc.
In 2008, the isar shock trial showed that hemodynamic support increased at 30 minutes with impella, but 30day mortality was the same in the impella and iabp study groups. Support for diagnostic, percutaneous revascularization, and interventional procedures. Healthdaysix variables can be combined to predict shortterm mortality risk in patients with cardiogenic shock cs, according to a study published in the april 18 issue of the journal of the. Learn vocabulary, terms, and more with flashcards, games, and other study tools. In this randomised, multicentre trial, iabp support did not reduce. Although there were some limitations to the study, including its relatively. No survival benefit of balloon pump in ami with shock. Oct 28, 2012 the balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. The effectiveness of intraaortic balloon pump for myocardial. In the iabp shock ii trial and registry, patients with missing data with. Iabp deployment in critical care home critical care and shock. The intraaortic balloon pump in cardiogenic shock ii iabpshock ii trial randomized 600 patients with acute mi complicated by cardiogenic shock to either iabp or no iabp. The goal of the trial was to evaluate treatment with an impella percutaneous left ventricular assist device lvad compared with an intraaortic balloon pump iabp in patients with cardiogenic shock due to acute myocardial infarction ami.
Intraaortic balloon pump in cardiogenic shock ii full text view. The national centre of health statistics estimated that iabp was used in 42 000 patients in the. The isar shock efficacy study of lv assist device to treat patients with cardiogenic shock trial randomized 26 patients between iabp and the impella 2. Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock uta c. Intraaortic balloon support for myocardial infarction with cardiogenic shock. Sep 18, 2012 so why you would use an iabp, such a complicated, expensive and invasive machine that might help unload the heart in systole, and gives you a tiny 510 mmhg extra in diastole is beyond me the shock ii trial actually reports no changeimprovement in blood pressure in the iabp arm. Iabpshock ii hotline esc final 082012 clinical trial results. Cs is characterized by permanent or transient rearrangement of the entire. Continuing the trajectory seen at 30 days and 1 year, the longterm data from the iabpshock ii trial reported today show no survival benefit for intraaortic balloon pump iabp use in acute mi cardiogenic shock patients. The iabp shock ii trial 3 table 1 was the first large prospective, randomised, openlabel, multicentre trial, to investigate the influence of iabp support on mortality. The balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. In the setting of cs, 2 small trials have been performed with the impella 2.
Intraaortic balloon counterpulsation in patients with. Cardiogenic shock cs is the most common cause of death for patients hospitalized with acute myocardial infarction mi. Cardiogenic shock cs is a clinical condition of inadequate tissueend organ perfusion due to cardiac dysfunction hypotension sbp iabpshockii randomized trial manesh r. Interimsanalyse meilenstein 4 letzter patient jahr 1 jahr 2 jahr 3 jahr 4 jahr 5 patientenrekrutierung followup vorbereitung studienprotokoll, ek, etc.
There are no randomized study data available for ecmo use. At 30 days, there was no significant difference in mortality 50% for iabp versus 46% for impella. The use of intraaortic balloon pump iabp in stsegment elevation myocardial infarction stemi presenting in cardiogenic shock cs has recently been challenged by the pivotal study iabp shock ii trial thiele h et al. According to the score, the population was classified into three risk categories. In current international guidelines the recommendation for intraaortic balloon pump iabp use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. Iabpshock ii risk score for patients with cardiogenic. Intraaortic balloon counterpulsation therapy has been the firstline strategy for patients requiring mechanical circulatory support for more than 40 years. Wartono from the division of cardiothoracic surgery, department of surgery. Intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction. Although iabps hemodynamic benefits are not disputed, its impact on hard outcomes remains questionable. Intraaortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock. Recently, the large randomized iabpshock ii trial did not show a significant reduction in 30day mortality in csmi with iabp insertion. It was for these reasons that the iabp shock ii trial was designed, aiming to show that the iabp can improve.
A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Evidence for the use of iabp in mi and cardiogenic shock. Section editor huiping zhang department of cardiology, beijing hospital, the. Clinical study of intraaortic balloon pump use in cardiogenic shock complicating. This is a substudy of the randomized iabpshock ii trial. This study sought to develop an easytouse, readily available risk. Risk stratification for patients in cardiogenic shock after acute. Intraaortic balloon pump therapy does not improve mortality in acute myocardial infarction in the populations studied in rcts, regardless of the presence or absence of cardiogenic shock. In an openlabel, multicenter, industrysupported, german trial, researchers randomized 600 patients with ami and cardiogenic shock to iabp or no iabp. Patel, md crt 20 consulting johnson and johnson grant support johnson and johnson maquet gmbh and co.
Treatment options in cardiogenic shock with intraaortic. Vol 382 november 16, 20 intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabpshock ii. P2269 iabpshock ii risk score validation for cardiogenic shock. Use of intraaortic balloon pump in cardiogenic shock. In the only adequately powered randomized trial of iabp in cs secondary to myocardial infarctioniabpshock ii intraaortic balloon pump in cardiogenic shock ii trialshort and midterm followup data at 30 days and 1 year showed no survival benefit with iabp support in comparison to control, nor any benefit with respect to secondary. However, some previous trials in cardiogenic shock showed a mortality benefit at longer followup. Oct 25, 2012 objectives the iabpshock ii trial was designed to test the hypothesis that intraaortic balloon counterpulsation, as compared with the best available medical therapy alone, results in a reduction in mortality among patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization is planned 4. Overall, 480 patients were included in the final analysis. So why you would use an iabp, such a complicated, expensive and invasive machine that might help unload the heart in systole, and gives you a tiny 510 mmhg extra in diastole is beyond me the shock ii trial actually reports no changeimprovement in blood pressure in the iabp arm. Percutaneous mechanical circulatory support versus intra.
Intraaortic balloon pump counterpulsation iabp is currently the most commonly used mechanical assist device for patients with cardiogenic shock due to acute myocardial infarction. At 30 days, there was no significant difference in the primary outcome of mortality between iabp and controls. This is the third trial to show impella did not have superiority over iabps. The linked article is a discussion of the impact of iabp together with thrombolysis in the shock trial should we emergently revascularize occluded coronary arteries for cardiogenic shock. As he name suggests, all patients had cardiogenic shock. Longterm iabpshock ii data offer rare look at poor. At 6 months, the mortality rate was 50% in both groups.
A model was developed on the randomized population of the iabpshock ii trial n 600 using a stepwise multivariable cox proportional hazards regression analysis with forward selection technique. Intraaortic balloon pump in cardiogenic shock state of the art 103 rev. Intraaortic balloon pump in myocardial infarction jama. It was for these reasons that the iabpshock ii trial was designed, aiming to show that the iabp can improve. The intraaortic balloon pump iabp is a myocardial assist device that was first introduced into clinical practice in 1968. The overall effect of the iabp therapy is an increase in the myocardial oxygen supplydemand ratio and thus in endocardial viability. Cardiovascular interventions1 that discussed the impact of clinical trials iabp shock ii, bcis1, and crispami on intraaortic balloon pump use in the cath lab. Thiele h1, zeymer u, neumann fj, ferenc m, olbrich hg, hausleiter j, richardt g, hennersdorf m, empen k, fuernau g, desch s, eitel i, hambrecht r, fuhrmann j, bohm m, ebelt h, schneider s, schuler g, werdan k. It is also important to note that the results of the iabpshock ii trial apply only to standard iabp technology. Key takeaways this substudy of the iabpshock ii trial sought to develop an easytouse, readily available risk prediction score for shortterm mortality in patients with amirelated cs undergoing pci. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabp shock ii. According to the current iabpshock ii trial, 74% of the patients.